Manually driven surgical cutting and fastening instrument

ABSTRACT

A surgical cutting and fastening instrument that includes an elongate channel that is attached to a handle assembly by an elongate shaft assembly. The elongate channel is configured to receive a cartridge and has a pivotally translatable anvil attached thereto and a knife bar supported therein. The anvil may be selectively opened and closed by manipulating a closure trigger supported by the handle assembly. The knife bar may be distally advanced through the elongate channel by actuating a firing trigger that cooperates with a reversible rotary drive supported by the handle assembly. The knife bar may also be retracted to its starting position by actuating the firing trigger after the reversible rotary drive has been shifted to a retraction orientation.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application claiming priority under35 U.S.C. §120 to U.S. patent application Ser. No. 13/662,950, entitledMANUALLY DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT, filed Oct.29, 2012, now U.S. Patent Application Publication No. 2013/0048697,which is a continuation application claiming priority under 35 U.S.C.§120 to U.S. patent application Ser. No. 11/475,412, entitled MANUALLYDRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT, filed on Jun. 27,2006, which issued on Dec. 4, 2012 as U.S. Pat. No. 8,322,455, theentire disclosures of which are hereby incorporated by reference herein.

BACKGROUND

The present invention generally concerns surgical instruments and, moreparticularly, surgical cutting and fastening instruments. The presentinvention may have application in conventional endoscopic and opensurgical instrumentation as well as application in robotic-assistedsurgery.

Surgical staplers have been used in the prior art to simultaneously makea longitudinal incision in tissue and apply lines of staples on opposingsides of the incision. Such instruments commonly include a pair ofcooperating jaw members that, if the instrument is intended forendoscopic or laparoscopic applications, are capable of passing througha cannula passageway. One of the jaw members receives a staple cartridgehaving at least two laterally spaced rows of staples. The other jawmember defines an anvil having staple-forming pockets aligned with therows of staples in the cartridge. The instrument includes a plurality ofreciprocating wedges which, when driven distally, pass through openingsin the staple cartridge and engage drivers supporting the staples toeffect the firing of the staples toward the anvil.

Over the years, a variety of improvements have been made to suchinstruments. For example, some surgical staplers have been manufacturedwith electrically powered or pneumatically powered drive mechanisms.Such staplers, while extremely effective and easy to use, can be costprohibitive for some users.

Consequently there is a need for a surgical stapling device that iseffective and easy to use, yet more economical than other poweredsurgical stapling devices.

SUMMARY

In one general aspect, the present invention is directed to a surgicalinstrument that comprises a handle assembly that supports a closuredrive that is configured to generate a closing motion and an openingmotion. A firing drive is supported by the handle assembly and isconfigured to selectively generate a rotary firing motion and a rotaryretraction motion upon manual actuation of a firing trigger that isoperably coupled to the handle assembly. An elongate shaft assembly iscoupled to the handle assembly and communicates with the closure driveand the firing drive to separately transfer the closing motion and therotary firing motion. Various embodiments of the surgical instrumentfurther comprises an end effector that is coupled to the elongate shaftassembly. The end effector comprises an elongate channel that is sizedto receive a staple cartridge therein. An anvil is pivotally coupled tothe elongate channel. The anvil is pivotally responsive to the open andclosing motions from the elongate shaft assembly. A cutting and severingmember is operably supported within the elongate channel and isresponsive to the rotary firing and retraction motions from the elongateshaft assembly. In various embodiments, the elongate channel may befabricated from metal utilizing conventional progressive die stampingtechniques. Likewise, the anvil may be stamped from a piece of metal toreduce manufacturing costs.

In another general aspect, the present invention is directed to a methodfor processing an instrument for surgery. The method may compriseobtaining a surgical instrument of the type describe above, sterilizingit and thereafter storing it in a sterile container.

In another general aspect, the present invention is directed to asurgical stapling and severing apparatus that comprises a handleassembly that movably supports a closure shuttle therein. A closuretrigger is operably supported by the handle assembly and is operable toapply a closing and opening force to the closure shuttle. An elongatespine assembly that has a distal end and a proximal end is oriented suchthat the proximal end is supported by the closure shuttle and the distalend is coupled to an elongate channel configured to receive a staplecartridge therein. An anvil is pivotally coupled to the elongatechannel. A closure tube assembly is supported on the elongate spineassembly and is coupled to the handle assembly. The closure tubeassembly cooperates with the anvil such that upon application of theclosure force to the closure shuttle, the spine assembly moves distallywithin the closure tube assembly causing the anvil to pivot to a closedposition and whereupon application of the opening force to the closureshuttle, the spine assembly moves proximally within the closure tubeassembly causing the anvil to pivot to an open position. A cutting andsevering member is operably supported within the elongate channel and ashifter assembly is supported in the handle assembly. The shifterassembly is selectively movable between a firing orientation and aretraction orientation. The shifter assembly cooperates with a firingtrigger such that upon actuation of the firing trigger when the shifterassembly is in the firing orientation, the shifter assembly applies arotary firing motion to the cutting and severing member to drive thecutting and severing member distally through the elongate channel andsuch that upon another actuation of the firing trigger when the shifterassembly is in the retraction orientation, the shifter assembly appliesa rotary retraction motion to the cutting and severing member to drivethe cutting and severing member proximally through the elongate channel.

DRAWINGS

Various embodiments of the present invention are described herein by wayof example in conjunction with the following Figures, wherein likenumerals may be used to describe like parts and wherein:

FIG. 1 is a perspective view of an embodiment of a surgical cutting andfastening instrument of the present invention;

FIG. 2 is a cross-sectional side elevational view taken along the line2-2 of FIG. 1 of an end effector embodiment of the present invention;

FIG. 3 is an enlarged side elevational view of a portion of a knife barof the end effector embodiment of FIG. 2;

FIG. 4 is an enlarged front view of the knife bar of the end effector ofFIG. 3;

FIG. 5 is an isometric view of the end effector of FIG. 2 at the distalend of the surgical cutting and fastening instrument of variousembodiments of the present invention with the anvil in the openposition;

FIG. 6 is an isometric exploded view of the end effector or implementportion and spine assembly of various embodiments of the presentinvention;

FIG. 7 is an isometric view of the end effector of FIG. 2 with the anvilin the open position and the staple cartridge largely removed exposing asingle staple driver and double staple driver and the wedge sled in itsstart position against a middle pin of the knife bar;

FIG. 8 is an isometric view of the end effector of FIG. 2 with the anvilin the open position and the staple cartridge completely removed and aportion of the elongate channel removed to expose the lowermost pin ofthe knife bar;

FIG. 9 is a side elevational view in cross-section showing a mechanicalrelationship between the anvil, elongate channel, and staple cartridgein the closed position of the surgical cutting and fastening instrumentof FIG. 1, the section generally taken along lines 9-9 in FIG. 5 toexpose the wedge sled, staple drivers, staples, but also depicting theknife bar along a longitudinal centerline;

FIG. 10 is an isometric exploded assembly view of a surgical cutting andfastening instrument embodiment of the present invention;

FIG. 11 is a side elevational view of the surgical cutting and fasteninginstrument of the present invention with the anvil in the open positionand the handle assembly shown in cross-section to illustrate thepositions of the various components housed therein;

FIG. 12 is a side elevational view of the surgical cutting and fasteninginstrument of the present invention with the anvil in the closedposition and the handle assembly shown in cross-section to illustratethe positions of the various components housed therein;

FIG. 13 is an isometric exploded assembly view of a planetary gearassembly embodiment of the present invention;

FIG. 14 is an end view of the planetary gear assembly of FIG. 13 withthe cover plate removed therefrom;

FIG. 15 is an isometric exploded assembly view of a shifter assemblyembodiment of the present invention;

FIG. 16 is a cross-sectional view of a handle assembly embodiment of thepresent invention in a starting position wherein the anvil is in theopen position;

FIG. 17 is another cross-sectional view of a handle assembly embodimentof the present invention with the closure trigger locked in the closedor clamped position resulting in the anvil being locked in the clampedor closed position;

FIG. 18 is another cross-sectional view of a handle assembly of thepresent invention illustrating movement of the closure trigger to aposition wherein it is unlocked from the handle portion;

FIG. 19 is another cross-sectional view of a handle assembly of thepresent invention illustrating the movement of the closure trigger tothe fully actuated position; and

FIG. 20 is an isometric view of an alternative anvil embodiment of thepresent invention.

DETAILED DESCRIPTION

Turning to the Drawings wherein like numerals denote like componentsthroughout the several views, FIG. 1 depicts a surgical stapling andsevering instrument 10 that is capable of practicing several uniquebenefits of the present invention. The surgical stapling and severinginstrument 10 incorporates an end effector 12 that is manually actuatedby manipulation of control members on a handle assembly 200 to which itis attached. A variety of different end effector constructions areknown. One type of end effector 12 that may be employed with variousembodiments of the present invention is depicted in FIGS. 1, 2, and 5-9.As can be seen in some of those Figures, the end effector 12 employs anE-beam firing mechanism (“knife bar”) 30 that advantageously controlsthe spacing of the end effector 12. Various aspects of E-beam firingmechanisms are described in U.S. Pat. No. 6,978,921, entitled SURGICALSTAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM, therelevant portions of which are herein incorporated by reference. As thepresent Detailed Description proceeds, however, those of ordinary skillin the art will appreciate that other knife and firing barconfigurations may be advantageously employed without departing form thespirit and scope of the present invention.

It will further be appreciated that the terms “proximal” and “distal”are used herein with reference to a clinician gripping a handle of aninstrument. Thus, the end effector 12 is distal with respect to the moreproximal handle assembly 200. It will also be understood that forconvenience and clarity, spatial terms such as “vertical” and“horizontal” are used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and absolute.

As can be seen in FIGS. 2, 6, and 7, the end effector 12 includes anelongate channel 20 that has a pivotally translatable anvil 40 attachedthereto. In one embodiment, the channel 20 may be fabricated from metalutilizing conventional progressive die techniques and may be providedwith corresponding openings for receiving the knife bar 30 therein. Suchmanufacturing methods may result in manufacturing costs that are lowerthan those conventional methods that are otherwise commonly employed tomanufacture the elongate channels.

The elongate channel 20 is configured to receive and support a staplecartridge 50 that is responsive to the knife bar 30 to drive staples 70into forming contact with the anvil 40. It will be appreciated that,although a readily replaceable staple cartridge is advantageouslydescribed herein, a staple cartridge consistent with aspects of thepresent invention may be permanently affixed or integral to the elongatechannel 20.

With particular reference to FIGS. 2-4, in various embodiments, theknife bar 30 includes three vertically spaced pins that control thespacing of the end effector 12 during firing. In particular, an upperpin 32 is staged to enter an anvil pocket 42 near the pivot between theanvil 40 and elongate channel 20. When fired with the anvil 40 closed,the upper pin 32 advances distally within a longitudinal anvil slot 44extending distally through anvil 40. Any minor upward deflection in theanvil 40 is overcome by a downward force imparted by the upper pin 32.

Knife bar 30 also includes a lower most pin 34, or knife bar cap, thatupwardly engages a channel slot 23 formed in the elongate channel 20,thereby cooperating with the upper pin 32 to draw the anvil 40 and theelongate channel 20 slightly closer together in the event of excesstissue clamped therebetween. In various embodiments, the knife bar 30may advantageously include a middle pin 36 that passes through a firingdrive slot 52 formed in a lower surface of the cartridge 50 and anupward surface of the elongate channel 20, thereby driving the staples70 therein as described below. The middle pin 36, by sliding against theelongate channel 20, advantageously resists any tendency for the endeffector 12 to be pinched shut at its distal end. However, the uniqueand novel aspects of various embodiments of the present invention may beattained through use of other knife bar arrangements.

Returning to FIGS. 2-4, a distally presented cutting edge 38 between theupper and middle pins 32, 36 on the knife bar 30 traverses through aproximally presented, vertical slot 54 in the cartridge 50 to severclamped tissue. The affirmative positioning of the knife bar 30 withregard to the elongate channel 20 and anvil 40 assure that an effectivecut is performed.

The end effector 12 of the surgical stapling and severing instrument isdepicted in further detail in FIGS. 5-10. As will be described infurther detail below, manipulation of various control members on thehandle assembly 200 produces separate and distinct closing and firingmotions that actuate the end effector 12. The end effector 12advantageously maintains the clinical flexibility of this separate anddistinct closing and firing (i.e., stapling and severing).

FIG. 5 depicts the end effector 12, which is in an open position by aretracted spine assembly 100 (FIG. 6), with a staple cartridge 50installed in the elongate channel 20. On a lower surface 41 of the anvil40, a plurality of stapling forming pockets 46 are arrayed to correspondto a plurality of staple apertures 58 in an upper surface 56 of thestaple cartridge 50. The knife bar 30 is at its proximal position, withthe upper pin 32 aligned in a non-interfering fashion with the anvilpocket 42. The anvil pocket 42 is shown as communicating with thelongitudinal anvil slot 44 in the anvil 40. The distally presentedcutting edge 38 of the knife bar 30 is aligned with and proximallyremoved from the vertical slot 54 in the staple cartridge 50, therebyallowing removal of a spent cartridge 50 and insertion of an unfiredcartridge 50, which is snapfit into the elongate channel 20.Specifically, extension features 60, 62 of the staple cartridge 50engage recesses 24, 26, respectively (shown in FIG. 7) of the elongatechannel 20.

FIG. 6 shows an embodiment of an implement portion 12 of the surgicalstapling and severing instrument 10 in disassembled form. The staplecartridge 50 is shown as being comprised of a cartridge body 51, a wedgesled 64, single and double drivers 66, staples 70, and a cartridge tray68. When assembled, the cartridge tray 68 holds the wedge sled 64,single and double drivers 66, and staples 70 inside the cartridge body51.

The elongate channel 20 is coupled to the handle assembly 200 by meansof a spine assembly 100 that includes a distal spine section 110 and aproximal spine section 130. The elongate channel 20 has proximallyplaced attachment cavities 22 that each receive a corresponding channelanchoring member 114 formed on the distal end 112 of the distal spinesection 110. The elongate channel 20 also has anvil cam slots 28 thatpivotally receive a corresponding anvil pivot 43 on the anvil 40. Aclosure sleeve assembly 170 is received over the spine assembly 100 andincludes distal closure tube segment 180 and a proximal closure tubesegment 190. See FIG. 6. The distal closure tube segment 180 includes adistally presented tab 182 that engages an anvil closure tab 48proximate but distal to the anvil pivots 43 on the anvil 40 to therebyeffect opening and closing of the anvil 40 by axially moving the spineassembly 100 within the closure tube assembly 170 as will be discussedin further detail below.

With particular reference to FIG. 7, a portion of the staple cartridge50 is removed to expose portions of the elongate channel 20, such asrecesses 24, 26 and to expose some components of the staple cartridge 50in their unfired position. In particular, the cartridge body 51 (shownin FIG. 6) has been removed. The wedge sled 64 is shown at its proximal,unfired position with a pusher block 65 contacting the middle pin 36(not shown in FIG. 7) of the knife bar 30. The wedge sled 64 is inlongitudinal sliding contact upon the cartridge tray 68 and includeswedges 69 that force upward the single and double drivers 66 as thewedge sled 64 moves distally. Staples 70 (not shown in FIG. 7) restingupon the drivers 66 are also forced upward into contact with the stapleforming pockets 42 on the anvil 40 to form closed staples. Also depictedis the channel slot 21 in the elongate channel 20 that is aligned withthe vertical slot 54 in the staple cartridge 50.

FIG. 8 depicts the end effector 12 of FIG. 7 with all of the staplecartridge 50 removed to show the middle pin 36 of the knife bar 30 aswell as portion of the elongate channel 20 removed adjacent to thechannel slot 21 to expose the lower pin or knife bar cap 34. Projectingdownward from the anvil 40 near the pivot, a pair of opposing tissuestops 45 prevent tissue from being positioned too far up into the endeffector 12 during clamping.

In other embodiments of the present invention, the anvil employed maycomprise an anvil 40′ that is stamped or otherwise formed out of metalor other suitable material as illustrated in FIG. 20 to reducemanufacturing costs. As can be seen in that Figure, the anvil 40′ may beprovided with a slot 44′ for accommodating movement of a firing bartherethrough and also be formed with anvil pivots 43′ and a closure tab(not shown) to facilitate its operation in the manner described abovewith respect to anvil 40. In this embodiment, the lower surface 41′ ofthe anvil is not provided with staple forming pockets. The staplessimply close as they come into contact with the hard lower surface 41′.Also, the embodiment depicted in FIG. 20 is formed with tissue stops45′. Those of ordinary skill in the art will understand, however, thatthe anvil 40′ may be formed with or without staple forming pockets andtissue stops if so desired. In addition, other variations of stampedanvils may be employed without departing from the spirit and scope ofthe present invention.

FIG. 9 depicts the end effector 12 closed in a tissue clamping positionwith the knife bar 30 unfired. The upper pin 32 is in the anvil pocket42, vertically aligned with the anvil slot 44 for distal longitudinalmovement of the knife bar 30 during firing. The middle pin 36 ispositioned to push the wedge sled 64 distally so that wedges 69sequentially contact and lift double drivers 66 and the respectivestaples 70 into forming contact with staple forming pockets 42 in thelower surface 41 of the anvil 40.

As indicated above, the channel 20 is coupled to the handle assembly 200by a spine assembly 100 that, in various embodiments, consists of adistal spine section 110 and a proximal spine section 130. As can beseen in FIG. 6, the distal spine section 110 has a distal end 114 thatis attached to the elongate channel 20 and a proximal end 116 that isattached to a distal end 132 of the proximal spine section 130. Theknife bar 30 is slidably received in a distal slot 118 in the distal endof the distal spine segment 110. A proximal end 31 of the knife bar 30has an upstanding connector tab 33 formed thereon that is adapted to bereceived in a slot 162 in a connector block 160. The connector block 160is attached to a firing rod 210 that is slidably supported within theproximal spine section 130. The connector block 160 is sized to beslidably received within a proximal slot 120 in the distal spine section110.

The firing rod 210 may be fabricated from a polymer or other suitablematerial and be configured with a hollow shaft portion 212 that is sizedto permit it to axially travel within the proximal slot 120 in thedistal spine section 110. The firing rod 210 further has a proximalconnector portion 220 that is sized to axially travel within an axialpassage in the proximal spine section 130 as will be discussed infurther detail below. The connector block 160 has a connector tab 164protruding therefrom that is sized to be frictionally inserted into thetapered end 214 of the hollow shaft portion 212 of the firing rod 210.The tapered end 214 may have a series of slits 216 provided around itscircumference to enable the protruding connector tab 164 on theconnector block 160 to be inserted into the tapered end 214 and befrictionally attached thereto.

As can also be seen in FIG. 6, the proximal spine section 130 may befabricated in two pieces to facilitate easy installation of the firingrod 210 therein and attachment to the distal spine section 110. Morespecifically, the proximal spine section 130 may comprise a rightproximal spine segment 140 and a left proximal spine segment 150. Theright proximal spine segment 140 has a right axial passage portion 146that cooperates with a left axial passage portion 156 in the leftproximal spine segment 150 to form an axial passage 132 in the proximalspine section 130 that is sized to axially and movably support theconnector portion 220 of the firing rod 210 therein. In addition, thedistal end 142 of the right spine segment 140 has a groove 144 thereinthat cooperates with a groove 154 in the distal end 152 of the leftspine segment 150 to form an annular retention groove (not shown) in theproximal spine segment 130 for rotatably receiving a connection tab 124protruding from the distal end 132 of the proximal spine section 130.Such arrangement permits the distal spine section 110 to be rotatedrelative to the proximal spine section 130. See arrow “A” in FIG. 6.

In various embodiments, the firing rod 210 is axially movable within theproximal spine section 130 by a firing screw 240, the operation of whichwill be discussed in further detail below. The firing screw 240 iscoupled to the firing rod 210 by a bifurcated firing nut 244 thatcomprises nut segments 246 and 248. Nut segment 246 has an upstandingtab 247 protruding therefrom that is sized to protrude through a slot222 in the connection portion 220 of the firing rod 210. Likewise, thenut segment 248 has an upstanding tab 249 that is sized to protrudethrough a slot (not shown) in the connection portion 220 of the firingrod 210. The portion of the tabs 247, 249 that protrude outward from theconnection portion 220 are received in axial slots formed in theproximal spine segments 140, 150. Such tabs 247, 249 and slots, serve tofacilitate axial travel of the firing rod 210 within the proximal spinesegment 140 without permitting rotation of the firing rod 210 relativeto the proximal spine segment 130.

Journaled on the spine assembly 100 is the closure tube assembly 170.See FIG. 6. The closure tube assembly 170 comprises a distal closuretube segment 180 and a proximal closure tube segment 190. The distalclosure tube segment 180 and the proximal closure tube segment 190 maybe fabricated from a polymer or other suitable material. The proximalclosure tube segment 190 is hollow having an axial passage 192 extendingtherethrough that is sized to receive the spine assembly 100 therein. Anaxially extending slit 193 may be provided in the proximal closure tube190 to facilitate easy installation of the spine assembly 100 therein.The distal end 194 of the proximal closure tube segment 190 may beprovided with an extension 196 over which the proximal end 184 of thehollow distal closure tube segment 180 is inserted. The two closure tubesegments 180, 190 may then be attached together with an appropriateadhesive material. The proximal end 196 of the proximal closure tubesegment may be provided with a flange 197, the purpose of which will bediscussed below.

FIG. 10 illustrates an exploded view of the handle assembly 200 and thecomponents housed therein of various embodiments of the presentinvention for controlling the movement of the spine assembly 100 and theknife bar 30. As can be seen in that Figure, the handle assembly 200comprises a pistol grip-type housing 250 that is fabricated in twopieces. For example, the housing 250 may comprise a right hand casemember 260 and a left hand case member 280 that are molded or otherwisefabricated from a polymer material and are designed to mate together.Such case members 260 and 280 may be attached together by snap features,pegs and sockets molded or otherwise formed therein and/or by adhesive,screws, etc.

Supported within the housing 250 is a closure shuttle 300 that iscoupled to a closure trigger 320 by a linkage assembly 330. Closureshuttle 300 may be configured as shown in FIG. 10 with a distal cradleportion 310 and a proximal cradle portion 314. The distal cradle portion310 is configured to cradle the proximal end 136 of the proximal spinesegment 130 therein. A base flange 138 is formed on the proximal end 136of the proximal spine segment 130 and is received within a slot 312 inthe closure shuttle 300. The base flange 138 is formed by a right sideflange segment 149 formed on the proximal end 145 of the right proximalspine segment 140 and a left side flange segment 159 formed on theproximal end 154 of the left proximal spine segment 150. See FIG. 6.

As can be seen in FIG. 10, the closure shuttle 300 is provided withlaterally extending rails 302 that are configured to be slidablyreceived within rail guides 262 and 282 in the right hand case member260 and left hand case member 280, respectively. Such arrangementpermits the closure shuttle 300 to move axially in a distal direction(arrow “B”) and a proximal direction (arrow “C”) within the handlehousing 250. Axial movement of the closure shuttle 300 (and the spineassembly 100) in the distal direction is created by moving the closuretrigger 320 toward the pistol grip portion 252 of the handle housing 250and axial movement of the closure shuttle 300 in the proximal direction(arrow “C”) is created by moving the closure trigger 320 away from thepistol grip portion 252.

In various embodiments, the closure shuttle 300 is provided with aconnector tab 304 that facilitates the attachment of the closure linkageassembly 330 thereto. See FIGS. 10-12. The closure linkage assembly 330includes a closure arm 340 and a closure link 350. The closure arm 340is pivotally pinned within the housing 250 by a closure pin 344 thatextends through a first pivot hole 342 in the closure arm 340. The endsof the closure pin 344 are received in sockets 264 formed in the righthand case member 260 and left hand case member 280. Such arrangementpermits the closure arm 340 to pivot about a first closure axis 346. SeeFIG. 10. The distal end 341 of the closure arm 340 is pinned to aproximal end 351 of the closure link 350 such that the proximal end 351of the closure link 350 can pivot relative to the distal end 341 of theclosure arm 340 about a proximal pivot axis 355. Likewise, the distalend 352 of the closure link 350 is pinned to the connection tab 304 onthe closure shuttle 300 such that the distal end 355 can pivot relativeto the connection tab 304 about a distal pivot axis 357. See FIG. 11.

FIG. 11 illustrates the end effector 12 in an open (unclamped) position.As can be seen in that Figure, the closure trigger 320 is pivoted awayfrom the pistol grip portion 252 and the closure shuttle 300 is in itsproximal position. When the closure shuttle 300 is in the proximalposition, it draws the spine assembly 100 in the proximal “C” directionwithin the closure tube assembly 170. Such axial movement of the spineassembly 100 within the closure tube assembly 170 causes the closure tab48 on the anvil to engage tab 182 on the distal closure tube segment 180in such a manner as to cause the anvil 40 to pivot to the open position.

When the clinician desires to close the anvil 40 and to clamp tissuewithin the end effector 12, the clinician draws the closure trigger 320toward the pistol grip 252 as shown in FIG. 12. As the clinician drawsthe closure trigger 320 toward the pistol grip 252, the closure linkageassembly 330 moves the closure shuttle 300 in the distal “B” directionuntil the closure linkage assembly 330 moves into the locked positionillustrated in FIG. 12. When in that position, the linkage assembly 330will tend to retain the closure shuttle 300 in that locked position. Asthe closure shuttle 300 is moved to the locked position, the spineassembly 100 is moved proximally within the closure tube assembly 170causing the closure tab 48 on the anvil to contact the tab 182 on thedistal closure tube segment 180 to thereby pivot the anvil 40 to theclosed (clamped) position.

In various embodiments, to further retain the closure shuttle 300 in theclosed position, the closure trigger 320 may be provided with areleasable locking mechanism that is adapted to engage the pistol grip252 and releasably retain the closure trigger in the locked position.Other locking devices may also be used to releasably retain the closureshuttle 300 in the locked position. In the embodiment depicted in FIGS.11 and 12, a lock member 322 in the form of a piece of spring steel orother flexible material is attached to the closure trigger 320. The freeend of the lock member 322 is situated to enter into a retention pocket254 in the pistol grip portion 252 of the handle 250. The lock member322 frictionally engages the retention pocket 254 and retains theclosure trigger 320 in the closed position.

To release the closure trigger 320 and thereby permit it to be pivotedto the open position, the clinician simply draws the closure trigger 320further inward toward the pistol grip portion 252 as shown in FIG. 18.As the lock member 322 is moved further into the retention pocket 254,the end of the lock member 322 contacts a sloped surface 258 in the rearof the retention pocket 254 which causes the lock member 322 to flex asufficient amount to permit it to release from the retention pocket 254thereby permitting the closure trigger 320 to move away from the pistolgrip 252 (FIG. 16). Other releasable locking arrangements could also beemployed.

As indicated above, the advancement and retraction of the knife bar 30is controlled by the firing rod 210 and rotary driven firing screw 240.The firing screw 240 has a splined proximal end 242 that is configuredto be coupled to a planetary gear assembly 400 that is supported in theproximal cradle portion 314 of the closure shuttle 300. One embodimentof a planetary gear assembly 400 is depicted in FIGS. 13 and 14. As canbe seen in those Figures, the planetary gear assembly 400 includes aplanetary case 410 that has a ring gear 412 formed therein. Theplanetary case 410 supports a first stage gear assembly 420 that has a3:1 ratio and a second stage gear assembly that has a 3:1 ratio.

The first stage gear assembly 420 includes a first sun gear 422 that iskeyed onto an input shaft 414 with a key 416. The input shaft 414protrudes through a coverplate 418 that mates with the planetary gearcase 410 and serves to seal the first stage gear assembly 420 and secondstage gear assembly 440 therein. In various embodiments, the first stagegear assembly 420 comprises three first planetary gears 424, 426, 428that are journaled on corresponding planetary spindles 425, 427, 429,respectively that are attached to a first planetary plate 430. The firstplanetary gears 424, 426, 428 are in meshing engagement with the firstsun gear 422 and the ring gear 412 in the planetary gear case 410. Ascan be seen in FIG. 13, a first output shaft 432 is attached to thefirst planetary plate 430 with a key 434.

The second stage gear assembly 440 includes a second sun gear 442 thatis also keyed to the first output shaft 432 by key 434. Three secondplanetary gears 444, 446, 448 are in meshing engagement with the secondsun gear 442 and the ring gear 412. The second planetary gears 444, 446,448 are journaled on three corresponding second planetary spindles 445,447, 449 that are attached to a second planetary plate 450. A secondoutput shaft 460 is keyed to the second planetary plate 450 by key 462.The second output shaft 460 has an elongate shaft portion 464 thatextends through a thrust bearing assembly 470. As can be seen in FIG.13, the thrust bearing assembly 470 includes a bearing cage 472 thatsupport a plurality of bearings 474. The bearing cage 472 and bearings474 are located between first and second thrust washers 476 and 478. Theelongate shaft portion 464 protrudes through a distal end of theplanetary case 410 and is attached to a shaft coupler 480 with a pin ora set screw 482. The shaft coupler 480 is internally splined and adaptedto receive therein a splined proximal end 242 of the firing screw 240.

As was indicated above, the movement of the knife bar 30 in the distaldirection (“B”) is ultimately controlled by the rotation of the firingscrew 240 which drives the firing rod 210 and ultimately the knife bar30. Thus, by rotating the firing screw 240 in the clockwise direction(arrow “D” in FIG. 13) the firing bar 210 is advanced distally (“B”).The rotation of the firing screw 240 is ultimately controlled by aunique and novel shifter assembly 500. As will be discussed in furtherdetail below, the shifter assembly 500 transmits rotational power to theplanetary gear set 400 and ultimately to the firing screw 240.

In various embodiments, the shifter assembly 500 includes a shifter case510 that is supported in the housing 250. As can be seen in FIG. 15, theshifter case 510 includes a left hand support arm 520 and a right handsupport arm 540 that are separated by a central support member 530. Aleft hand pinion gear 550 is rotatably supported in a hole 522 in theleft hand support arm 520. A right hand pinion gear 560 is similarlyrotatably supported within a hole 542 in the right hand support arm 540.A central bevel gear 570 is rotatably supported in a hole 532 in thecentral support member 530 and is centrally disposed between the righthand pinion gear 560 and left hand pinion gear 550 and is in meshingengagement therewith such that rotation of the central bevel gear causesthe right hand pinion gear 560 to rotate in the clockwise “D” directionand the left hand pinion gear 550 to rotate in a counterclockwise “E”direction.

As can be seen in FIG. 15, a ratchet disc 580 is keyed to the centralbevel gear 570 with a key 572. Thus, when the ratchet disc 580 isrotated, it causes the central bevel gear 570 to rotate with it. Invarious embodiments, the shifter assembly 500 further includes a drivedisc 590 that has a series of drive springs 594 protruding therefromaround its circumference. The drive springs 594 may be fabricated fromspring steel or similar material and each have an attachment stemportion 595 that is inserted into corresponds slots 592 in the drivedisc 590. The drive springs 594 may be retained within the correspondingslots 592 by virtue of a friction fit or appropriate adhesive may alsobe used. The ends 596 of the drive springs 594 protrude out from thedrive disc 590 to engage tooth-like ratchet grooves 582 formed into theratchet disc 580. Thus, when the drive disc 590 is rotated in thedirection represented by arrow “F” in FIG. 15, the ends 596 of the drivesprings 594 engage the corresponding tooth-like ratchet grooves 582 inthe ratchet disc 580 and cause the ratchet disc 580 and central bevelgear 570 to rotate in the “F” direction. However, when the drive disc590 is rotated in the opposite direction represented by arrow “G” inFIG. 15, the drive springs 594 simply ratchet or slip over thetooth-like ratchet grooves 582 in the ratchet disc 580 and do nottransmit rotation to the ratchet disc 580 and central bevel gear 570. Inaddition, a drive gear 600 is keyed onto a case spindle 604 that isrotatably supported in a spindle socket 266 provided in the right handcase member 260 by a key 602. See FIGS. 10 and 15.

The drive gear 600 is adapted to be drivingly engaged by a firing gearsegment 620 formed on an upper end portion 612 of firing trigger 610.More specifically and with reference to FIG. 10, a firing trigger 610 isrotatably supported on a firing post 268 that protrudes from the righthand case member 260 and is received in a corresponding socket (notshown) in the left hand case member 280. The firing post 268 extendsthrough a hole 614 in the upper end of the firing trigger 610 such thatthe firing trigger 610 can be freely pivoted thereon. The firing trigger610 may be fabricated from a polymer material and have a segment of gearteeth 620 formed on the upper end 612 of the firing trigger 610 asshown. The gear teeth 622 are adapted to selectively mesh with the teeth602 of the drive gear 600. As can be seen in FIGS. 16-19. the upper endportion 612 of the firing handle 610 has an arcuate shape. The gearsegment 620 is formed on the proximal portion 613 of the upper endportion 612 and a stop member 626 is formed on the distal portion 614 ofthe upper end portion 612.

FIG. 16 illustrates the firing trigger 610 in the neutral (unfired)position. As can be seen in that Figure, when in that position, the gearteeth 602 of the drive gear 600 that are adjacent the upper end 612 ofthe firing trigger 610 are not in meshing engagement with the gearsegment 620 on the upper end 612 of the firing trigger 610. A firinghandle return spring 630 extends between a post 284 on the left handcase member 280 and a post 617 on the upper end 612 of the firingtrigger 610. The spring 630 serves to pull the firing trigger 610 intothe position shown in FIG. 16. The gear teeth 602 on the drive gear 600contact the stop member 626 formed on the upper end 612 of the firingtrigger 610 to retain the firing trigger 610 in that position and toprevent the firing trigger 610 from rotating in the “G” direction beyondthat position. Those of ordinary skill in the art will appreciate thatwhen the clinician draws the firing trigger 610 toward the pistol grip252 (direction “H”), the gear segment 620 begins to mesh with the gearteeth 602 on the drive gear 600 (FIG. 17) and causes the drive gear 600to rotate in the direction “I”. Once the clinician reaches the end ofthe stroke, the firing trigger 610 is released and the return spring 630causes the firing trigger 610 to move to the unfired position depictedin FIG. 16.

The rotational direction of the firing screw 240 is controlled by ashifter gear 650 located in the shifter assembly 500. As can be seen inFIG. 15, the shifter gear 650 is centrally disposed between the righthand bevel gear 560 and the left hand bevel gear 550 and is movable by ashift arm yoke 660 into engagement with those gears 550, 560. Morespecifically, the shifter gear 650 has a proximal set of gear teeth 652formed thereon for selective meshing engagement with the right handpinion gear 560. In addition, the shifter gear 650 has a distal set ofgear teeth 654 formed thereon for selective meshing engagement with theleft hand pinion gear 550.

In various embodiments, a shifter shaft 680 is coupled to the firstinput shaft 414 of the planetary gear set 400 and the shifter gear 650.In particular, the shifter shaft 680 has a distal end 682 that isattached to a first coupler 684 by a set screw, adhesive, welding, etc.which is in turn attached to the first input shaft 414 by a set screw,adhesive, welding, etc. The shifter shaft 680 has a splined portion 686that extends through a hole 552 in the left hand pinion gear 550. Theleft hand pinion gear 550 does not engage the splined portion 686 of theshifter shaft 680 and can freely rotate in either direction relativethereto. The splined section 686 of the shifter shaft 686 also mayextend into a hole 562 in the right hand pinion 560. However, the righthand pinion 560 does not engage the splined section and can freelyrotate relative thereto. The splined section 686 of the shifter shaft680 extends into a splined hole 655 in the shifter gear 650 such thatthe shifter gear 650 can move axially on the splined section (arrows“J”), but transmits rotation to the shifter shaft 680 by means of thesplined interconnection therebetween.

As can be seen in FIG. 15, a yoke groove 656 is formed around thecircumference of the shifter gear 650. The yoke 660 includes twoopposing yoke arms 662 that each have an inwardly extending pin 664thereon that is received in the yoke groove 656. Such arrangementpermits the shifter gear 650 to rotate relative to the yoke 660.However, the yoke 660 may be used to move the shifter gear 650 axiallyon the splined section 686 of the shifter shaft 680 between the lefthand pinion gear 550 and the right hand pinion gear 560. The shifterassembly 500 has a top member 514 that is attached to the shifter case510 by adhesive or other suitable fastener means. A shifter arm 667protrudes from the yoke portion 660 and extends through an opening 513the top member 514 and is pivotally pinned thereto by a shift arm pin517. A shifter button 519 is attached to the top end of the shifter arm667 by adhesive, etc.

In various embodiments, a shifter spring 700 is pinned or otherwiseattached to the top of the shifter arm 667 and pinned or other wiseattached to the left hand case member 280 such that the shifter spring700 serves to pull the shifter arm 667 into the position shown in FIG.12 to thereby cause the proximal gear teeth 652 on the shifter gear 650to mesh with the gear teeth 564 on the right hand pinion gear 560. Whenin that position, the clinician can trigger the knife bar 30 byratcheting the firing trigger 610 as will be discussed below.

In use, the surgical stapling and severing instrument 10 is used asdepicted in FIGS. 1, 11, 12 and 16-19. In FIGS. 11 and 16, theinstrument 10 is in its start position, having had an unfired, fullyloaded staple cartridge 50 snap-fitted into the distal end of theelongate channel 20. Both triggers 320, 610 are forward and the endeffector 12 is open, such as would be typical after inserting the endeffector 12 through a trocar or other opening into a body cavity. Theinstrument 10 is then manipulated by the clinician such that tissue tobe stapled and severed is positioned between the staple cartridge 50 andthe anvil 40.

With reference to FIGS. 12 and 17, next, the clinician moves the closuretrigger 320 proximally until positioned directly adjacent to the pistolgrip 252 such that the retention member 256 frictionally engages theretention pocket 252 in the housing 250 locking the closure trigger 320in the closed and clamped position. When in that position, the closurelinkage 330 also serves to retain the closure trigger 320 in thatposition as shown in FIG. 12. The retracted knife bar 30 in the endeffector 12 does not impede the selective opening and closing of the endeffector 12, but rather resides within the anvil pocket 42. With theanvil 40 closed and clamped, the E-beam knife bar 30 is aligned forfiring through the end effector 12. In particular, the upper pin 32 isaligned with the anvil slot 44 and the elongate channel 20 isaffirmatively engaged about the channel slot 21 by the middle pin 36 andthe firing bar cap 34.

With reference to FIGS. 16-19, after tissue clamping has occurred, theclinician moves the firing trigger 610 proximally towards the pistolgrip portion 252. Such action cases the gear segment 620 on the upperend 612 of the firing trigger to engage and rotate the drive gear 600 inthe “I” direction. Rotation of the drive gear 600 in the “I” directioncauses the drive disc 590 to also rotate in that direction. As the drivedisc 590 rotates in that direction, the drive springs 594 engage theratchet teeth 582 on the ratchet disk 580 and cause the ratchet disc 580to also rotate in the “I” direction. The central bevel gear 570 alsorotates with the ratchet disc 580 because it is keyed thereto. As thecentral bevel gear 570 rotates, it also causes the left hand pinion gear550 to rotate in the “E” direction and the right hand pinion gear 560 torotate in the “D” direction. See FIG. 15.

When the shifter gear 650 is brought into meshing engagement with theright hand pinion gear 560 as shown in FIGS. 11 and 12, movement of thecentral bevel gear 570 causes the right hand pinion gear 560 and shiftergear 650 to rotate in the “D” direction. Because of the splinedconnection between the shifter shaft 680 and the shifter gear 650, theshifter shaft 680 is also caused to rotate in the “D” direction. Suchrotary drive motion is transferred to the firing screw 240 through theplanetary gear assembly 400. As the firing screw 240 rotates in the “D”direction, the firing bar 210 is driven distally which causes theconnection block 160 and knife bar 30 to move proximally. The cliniciancontinues to ratchet the firing trigger 610 until the knife bar 30 isreturned to the unfired position.

When the clinician has moved the firing trigger 610 to the proximalposition adjacent the closure trigger 320, the clinician can release thefiring trigger 610 and the return spring 630 will return the firingtrigger 610 to the unfired position (FIG. 16). As the firing trigger 610is returned to the unfired position, the gear segment 620 thereon willimpart a rotation in the “H” direction to the drive gear 600. The drivegear 600 also causes the drive disc 590 to rotate in the direction “H”.However, the drive springs 594 ratchet over the ratchet teeth 582 in theratchet disc 580 and thus the rotational motion is not transmittedthereto. The clinician continues to ratchet the firing trigger 610 untilthe knife bar 30 can no longer be advanced distally through thecartridge 50.

The clinician can then return the knife bar 30 to the unfired position,by moving the shifter button 519 in the distal direction to cause theshifter gear 650 to disengage the right hand pinion gear 560 and meshwith the left hand pinion gear 550. Thereafter, the clinician simplyratchets the firing trigger 610 in the same manner which causes the lefthand pinion gear 550 to rotate in the “E” direction. Such rotationalmotion is transmitted to the shifter shaft 680 and to the firing screw240 through the planetary gear assembly 400. As the firing screw 240rotates in the “E” direction, the nuts 247 draw the firing bar 210proximally. The firing bar 210 then draws the connector block 160 andknife bar 30 proximally until the knife bar 30 reaches the unfiredposition wherein the spent cartridge 50 may be removed from the elongatechannel 20 and replaced with a new unfired cartridge or, in thealternative the entire unit 10 may be properly discarded.

As can be appreciated from the above-described firing and retractionsequences, the firing and retraction actions are accomplished throughmultiple actuations of the firing trigger. For example, in oneembodiment, the clinician must actuate (i.e., move the firing handlefrom its unfired position (FIG. 16) to its fired position (FIG. 19)) sixtimes to completely fire all of the staples in a conventional 60 mm endeffector. Likewise, to completely retract the knife bar 30 to theunfired position wherein the staple cartridge 50 may be removed from theelongate channel 20, the clinician would have to move the shifter button519 to the retraction position and actuate the firing trigger an equalnumber of times—in this example six times. However, the unique and novelattributes and advantages of the present invention may be employed inconnection with a host of different sizes of end effectors. Thus, whenshorter end effectors are employed, less actuations of the firingtrigger may be required to completely fire the staples and thereafterreturn the knife bar to a fully retracted position. For example, it iswithin the scope of this invention to be employed with end effectorsthat would require only one or more than one actuations of the firingtrigger to fire the staples and only one or more than one actuations tomove the firing and cutting device to a fully retracted position.

As indicated above, the distal spine section 110 is attached to theproximal spine section 130 such that it can freely rotate relativethereto. Likewise, the closure tube assembly 170 can freely rotate onthe spine assembly 100. To facilitate rotation of the end effector 12relative to the handle assembly 200, the handle assembly 200 is providedwith a rotation grip assembly 710 that can be rotated relative to thehandle assembly 200 and cause rotation of the end effector 12. Morespecifically and with reference to FIGS. 1 and 10, the grip assembly 710comprises a right hand grip segment 720 and a left hand grip segment 730(shown in FIG. 1) that are adapted to mate with each other and rotatearound the distal end 251 of the housing 250. The right hand gripsegment 720 and left hand grip segment 730 may be fabricated frompolymers or other suitable materials and attached to each other by snapfeatures, adhesive, screws, etc. Each segment 720, 730 has an arcuaterail segment 722 formed therein that is adapted to ride in a groove 259formed in the housing 250 when the right hand case member 260 and lefthand case member 280 are attached together. Thus, the rail segments 722serve to retain the grip assembly 710 on the housing 250 whilefacilitating its rotation relative thereto. Each grip segment 720, 730further has a tube rotation segment 724 formed therein that cooperatetogether to extend into a hole 191 in the proximal closure tube segment190. Thus, rotation of the grip housing 710 relative to the handlehousing 250 causes the closure tube assembly 170 to rotate on theproximal spine segment 130. It will be understood that the distalclosure tube segment 180 does not rotate relative to the distal spinesection 110, but rather causes the distal spine section 110 to rotatewith it relative to the proximal spine section 130. The flange 197 onthe proximal end 196 of the proximal closure tube segment is receivedwithin a corresponding groove in the grip assembly 710. Such arrangementpermits the clinician to easily rotate the end effector 12 relative tothe handle assembly 200 after the end effector 12 has been insertedthrough the trocar into the patient.

While the present invention has been illustrated by description ofseveral embodiments and while the illustrative embodiments have beendescribed in considerable detail, it is not the intention of theapplicant to restrict or in any way limit the scope of the appendedclaims to such detail. Additional advantages and modifications mayreadily appear to those skilled in the art.

For example, by manufacturing the elongate channel utilizing conventiondies stamping techniques may lead to reduced manufacturing costs forthat component. Likewise by stamping the anvil from metal utilizingconventional stamping techniques can also reduce the manufacturing costscommonly encountered when manufacturing such components. In addition,the unique and novel ratchet drive arrangement for firing the deviceeliminates the need the for battery or pneumatically powered componentswhich can increase the overall cost of the device.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include an combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of particular pieces or parts of thedevice can be selectively replaced or removed in any combination. Uponcleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Those ofordinary skill in the art will appreciate that the reconditioning of adevice can utilize a variety of different techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

Preferably, the invention described herein will be processed beforesurgery. First a new or used instrument is obtained and, if necessary,cleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK® bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or higher energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

Any patent, publication, or information, in whole or in part, that issaid to be incorporated by reference herein is incorporated herein onlyto the extent that the incorporated material does not conflict withexisting definitions, statements, or other disclosure material set forthin this document. As such the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.

The invention which is intended to be protected is not to be construedas limited to the particular embodiments disclosed. The embodiments aretherefore to be regarded as illustrative rather than restrictive.Variations and changes may be made by others without departing from thespirit of the present invention. Accordingly, it is expressly intendedthat all such equivalents, variations and changes which fall within thespirit and scope of the present invention as defined in the claims beembraced thereby.

What is claimed is:
 1. A surgical instrument comprising: a handleassembly; a closure drive supported by said handle assembly andconfigured to generate a closing motion and an opening motion; a firingdrive supported by said handle assembly and configured to selectivelygenerate a rotary firing motion upon actuation of a firing triggeroperably coupled to said handle assembly and a rotary retraction motionupon another actuation of the firing trigger; an elongate shaft assemblycoupled to said handle assembly and communicating with said closuredrive and said firing drive to separately transfer said closing andopening motions and said rotary firing motion; and an end effectorcoupled to said elongate shaft assembly, said end effector comprising:an elongate channel sized to receive a staple cartridge therein; ananvil pivotally coupled to said elongate channel and being pivotallyresponsive to said open and closing motions from said elongate shaftassembly; and a cutting and severing member operably supported withinsaid elongate channel and being responsive to said rotary firing andretraction motions from said elongate shaft assembly.
 2. The surgicalinstrument of claim 1, wherein said elongate channel is metal and formedby stamping.
 3. The surgical instrument of claim 1, wherein said anvilis metal and formed by stamping.
 4. The surgical instrument of claim 1,wherein said elongate shaft assembly comprises: a spine assemblyattached to said closure drive and said elongate channel; and a closuretube assembly coupled to said handle assembly and extending over saidspine assembly, said spine assembly axially movable relative to saidclosure tube assembly in response to said closing and opening motionsgenerated by said closure drive, said closure tube assembly configuredto actuate said anvil between said open and closed positions in responseto said axial movement of said spine assembly within said closure tubeassembly.
 5. The surgical instrument of claim 4, wherein said spineassembly comprises: proximal spine section coupled to said handleassembly; and a distal spine section coupled to said proximal spinesection and being rotatable relative thereto.
 6. The surgical instrumentof claim 5, wherein said closure tube assembly is selectively rotatablerelative to said handle assembly.
 7. The surgical instrument of claim 4,wherein said closure drive comprises: a closure shuttle movablysupported by said handle assembly, said closure shuttle supporting aproximal end of said spine assembly therein; and a closure triggeroperably affixed to said handle assembly and said closure shuttle, saidclosure trigger operable to apply said closing and opening forces tosaid closure shuttle.
 8. The surgical instrument of claim 1, whereinsaid firing drive comprises: a firing rod supported within said elongateshaft assembly for selective axial travel therein, said firing rodcommunicating with said cutting and severing member such that upon anapplication of the rotary firing motion thereto, said firing rod causessaid cutting and severing member to move in a distal direction throughsaid elongate channel and upon application of the rotary retractionforce to said firing rod, said firing rod causes said cutting andsevering member to move in a proximal direction; and a shifter assemblysupported within said handle assembly and being selectively movablebetween a firing orientation for generating said rotary firing motionand a retraction orientation for generating said rotary retractionmotion; said shifter assembly communicating with said firing rod suchthat when said firing trigger is actuated when said shifter assembly isin firing orientation, said shifter assembly applies said rotary firingmotion to said firing rod and when said firing trigger is actuated whensaid shifter assembly is in said retraction orientation, said shifterassembly applies said rotary retraction motion to said firing rod. 9.The surgical instrument of claim 8, further comprising a shifter buttonsupported by said handle assembly for selectively moving said shifterassembly between said firing orientation and said retractionorientation.
 10. The surgical instrument of claim 8, wherein saidshifter assembly comprises: a first pinion gear operably supportedwithin said handle assembly; a second pinion gear operably supportedwithin said handle assembly; a central bevel gear in meshing engagementwith said first and second pinion gears; a ratchet assembly coupled tosaid central bevel gear and said firing trigger such that actuation ofsaid firing trigger causes said ratchet assembly to rotate said centralbevel gear in a first direction; and a shifter gear centrally disposedbetween said first and second pinion gears and being selectively movablebetween a position wherein said shifter gear meshes with said first gearand transmits said rotary firing motion to said firing rod and anotherposition wherein said shifter gear meshes with said second gear andtransmits said rotary retraction motion to said firing rod.
 11. Thesurgical instrument of claim 10, further comprising: a shifter shaftcoupled to said shifter gear; a gear assembly coupled to said shiftershaft; and a firing screw coupled to said gear assembly and said firingrod such that rotation of said firing screw in one direction causes saidfiring rod to move distally and rotation of said firing screw in anopposite direction causes said firing rod to move in a proximaldirection.
 12. A method for processing an instrument for surgery, saidmethod comprising: obtaining said surgical instrument of claim 1;sterilizing said surgical instrument; and storing said instrument in asterile container.
 13. A cutting and fastening instrument, comprising: ahandle assembly; a closure shuttle movably supported by said handleassembly; a closure trigger operably supported by said handle assemblyand operable to apply a closing and opening force to said closureshuttle; an elongate spine assembly having a distal end and a proximalend, said proximal end supported by said closure shuttle and said distalend coupled to an elongate channel configured to receive a staplecartridge therein; an anvil pivotally coupled to said elongate channel;a closure tube assembly supported on said elongate spine assembly andcoupled to said handle assembly, said closure tube assembly cooperatingwith said anvil such that upon application of said closure force to saidclosure shuttle, said spine assembly moves distally within said closuretube assembly causing said anvil to pivot to a closed position and uponapplication of said opening force to said closure shuttle, said spineassembly moves proximally within said closure tube assembly causing saidanvil to pivot to an open position; a cutting and severing memberoperably supported within said elongate channel; a shifter assemblysupported in said handle assembly and being selectively movable betweena firing orientation and a retraction orientation, said shifter assemblycooperating with a firing trigger such that upon actuation of saidfiring trigger when said shifter assembly is in said firing orientation,said shifter assembly applies a rotary firing motion to said cutting andsevering member to drive said cutting and severing member distallythrough said elongate channel and such that upon another actuation ofsaid firing trigger when said shifter assembly is in said retractionorientation, said shifter assembly applies a rotary retraction motion tosaid cutting and severing member to drive said cutting and severingmember proximally through said elongate channel.
 14. The surgicalinstrument of claim 13, wherein said elongate channel is metal andformed by stamping.
 15. The surgical instrument of claim 13, whereinsaid anvil is metal and formed by stamping.
 16. The surgical instrumentof claim 13, wherein said elongate channel is selectively rotatablerelative to said handle assembly.
 17. The surgical instrument of claim13, further comprising means for releasably retaining the closuretrigger in a locked position.
 18. The surgical instrument of claim 13,further comprising: a firing rod supported within a portion of saidelongate spine assembly for selective axial travel therein, said firingrod communicating with said shifter assembly and said cutting andsevering member such that upon an application of the rotary firingmotion to said firing rod, said firing rod causes said cutting andsevering member to move in a distal direction through said elongatechannel and upon application of the rotary retraction motion to saidfiring rod by said shifter assembly, said firing rod causes said cuttingand severing member to move in a proximal direction.
 19. The surgicalinstrument of claim 13, further comprising a shifter button supported bysaid handle assembly for selectively moving said shifter assemblybetween said firing orientation and said retraction orientation.
 20. Asurgical instrument comprising: a handle assembly; closure meanssupported by said handle assembly for generating a closing motion and anopening motion; firing means supported by said handle assembly formanually generating a rotary firing motion and a rotary retractionmotion upon manual actuation of a firing trigger operably coupled tosaid handle assembly; cartridge support means coupled to said handleassembly for supporting a staple cartridge therein; cutting meanssupported within said cartridge support means; force transmitting meanscoupled to said handle assembly and communicating with said closuremeans and said firing means to separately transfer said closing motion,said firing motion and said retraction motion to said cutting means; andanvil means pivotally coupled to said cartridge support means, saidanvil means being pivotally responsive to said open and closing motionsfrom said force transmitting means.